GpCRC Pediatric Gastroparesis Registry 2

Launched by JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH · Aug 1, 2023

Keywords

ClinConnect Summary

The Pediatric Gastroparesis Registry 2 is a clinical trial aimed at understanding gastroparesis, a condition where the stomach takes too long to empty its contents, and a related condition known as gastroparesis-like syndrome, where patients have similar symptoms but normal stomach emptying. This study is gathering information from children, teenagers, and young adults aged 8 to 25 who have experienced symptoms like nausea, vomiting, and feeling full after eating for at least 12 weeks. Participants need to have had a specific stomach test done in the last year to see how well their stomach empties.

If you or your child are between 8 and 25 years old and have been dealing with these symptoms, you might be eligible to join the trial. Participants will need to agree to follow the study rules and be available throughout the research period. This study aims to collect valuable data to help improve understanding and treatment of these conditions. Remember, participants will undergo a stomach function test, and certain medical conditions or medications may prevent eligibility, so it’s important to discuss any health concerns with the study team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Provision of signed and dated informed consent form and assent, as age appropriate.
• • Stated willingness to comply with all study procedures and availability for the duration of the study
• • 8 to 25 years of age at the time of enrollment
• * Symptoms of Gp of at least 12 weeks duration: constellation of some combination of:
• • nausea, vomiting, early satiety, postprandial fullness; symptoms sometimes may be accompanied by upper abdominal pain
• * Have undergone a gastric emptying scintigraphic study of solids using 4-hour Egg Beaters protocol (or equivalent generic liquid egg white meal) within the last 12 months who fall into one of the two categories:
• • Delayed gastric emptying-defined as an abnormal 2-hour (\>60% retention) and/or 4- hour (\>10% retention) result based on a 4-hour scintigraphic gastric emptying study
• • Gastric emptying that is not delayed but who have symptoms of Gp (designated in this study as GLS) or have previously participated in the Pediatric Gastroparesis Registry (PGpR) study
• • An etiology of either diabetic or idiopathic Gp or GLS
• Exclusion Criteria:
• • Inability to comply with or complete the scintigraphic gastric emptying test (including allergy to eggs)
• • Pregnancy
• • Autism spectrum disorder, significant developmental delay, psychosis (because of inability to complete questionnaires)
• • Use of narcotic analgesics greater than three days per week.
• • Presence of conditions associated with GI mucosal disease (e.g., inflammatory bowel disease, known eosinophilic gastroenteritis or eosinophilic esophagitis, gastric ulcer, peptic ulcer, celiac disease)
• • Presence of any other condition that could case delayed gastric emptying
• • Gastrointestinal construction confirmed by upper endoscopy (EGD), upper gastrointestinal series (UGI), or abdominal CT
• • Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious legions
• • Acute or chronic renal failure (abnormal creatinine for age) and /or on hemodialysis or peritoneal dialysis
• • Acute liver failure
• • Advanced liver disease (features of portal hypertension)
• • Clinically significant congenital heart disease (i.e., vaginal injury during cardiac repair)
• • History of esophageal, gastric or bowel surgery.
• • Metabolic disease including mitochondrial disease and inborn errors of metabolism
• • Chronic lung disease (including cystic fibrosis)
• • A serious chronic medical condition (e.g., inflammatory bowel disease)
• • Use of medications that can affect motility during the gastric emptying study
• • Any other condition, which in the option of the investigator, could explain the symptoms or could interfere with study requirements.